(267 days)
Not Found
No
The device description mentions a "motorized, microprocessor controlled bone cement delivery system," but there is no mention of AI, ML, or any learning or adaptive capabilities. The focus is on controlled delivery and warming of the cement.
Yes
The device is intended for the treatment of pathological fractures of the vertebrae, which means it is used to manage or cure a disease or condition.
No
The devices described (bone cement and a delivery system) are intended for treatment of pathological fractures, not for diagnosing them.
No
The device description clearly outlines both a bone cement (a physical material) and a motorized, microprocessor-controlled delivery system (hardware).
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the treatment of pathological fractures of the vertebrae using vertebroplasty or kyphoplasty procedures. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device description details a bone cement and a delivery system for that cement, both used directly in a surgical procedure on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside the body on biological samples to gain information about a patient's health status. This device is used inside the body to treat a condition.
N/A
Intended Use / Indications for Use
StabiliT ER Bone Cement:
The StabiliT ER Bone Cement is intended for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement):
The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT ER Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Product codes
NDN, KIH
Device Description
StabiliT ER Bone Cement*
The StabiliT ER Bone Cement is two-component PMMA bone cement with a powder component and a liquid component.
StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement)
StabiliT Vertebral Augmentation System is a motorized, microprocessor controlled bone cement delivery system intended for percutaneous delivery of bone cement in vertebroplasty or kyphoplasty procedures that allows for warming of the cement during cement delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vertebrae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of in-vitro testing (material, performance, mechanical, electrical) demonstrate that the StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) functioned as intended and the results of tests were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
510(K) SUMMARY OR 510(K) STATEMENT ട.
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: 04/06/09
510(k) number: __
ﺎ
Applicant Information:
DFine Inc. 3047 Orchard Parkway San Jose, CA 95134, USA
Contact Person
| Sandeep Saboo | |
|---|---|
| Phone Number: | 408-321-9999 ext 248 |
| Fax Number: | 408-321-9401 |
| e-mail: | sandeeps@dfineinc.com |
Device Information:
| Trade Name: | StabiliT ER* Bone Cement |
|---|---|
| StabiliT Vertebral Augmentation System | |
| Classification: | Class II (StabiliT ER* Bone Cement) |
| Class I (StabiliT Vertebral Augmentation System) | |
| Classification Name: | Bone Cement |
| Cement Dispenser |
Physical Description:
StabiliT ER* Bone Cement
The StabiliT ER Bone Cement is two-component PMMA bone cement with a powder component and a liquid component.
StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement)
StabiliT Vertebral Augmentation System is a motorized, microprocessor controlled bone cement delivery system intended for percutaneous delivery of bone cement in vertebroplasty or kyphoplasty procedures that allows for warming of the cement during cement delivery.
Intended Use:
StabiliT ERA Bone Cement
The StabiliT ER Bone Cement is intended for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement) The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT ER Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment
DFine Inc.
DEC 30 2009
1
of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Test Results:
Performance
Results of in-vitro testing (material, performance, mechanical, electrical) demonstrate that the StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) functioned as intended and the results of tests were as expected.
Biocompatibility
The materials used in the StabiliT ER' Bone Cement and StabiliT Vertebral Augmentation System (StabiliT ERA Bone Cement) meet the requirements of ISO 10993-1.
Substantial Equivalence and Summary:
The subject devices StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement) have the same intended use and indications, technological characteristics and principles of operation as their predicate, respectively, StabiliT ER Bone Cement (formerly known as SPACE CpsXL Bone Cement) [K072496] and SPACE 360 Delivery System (for use with SPACE CpsXL Bone Cement) [K070351] (also called StabiliT Vertebral Augmentation System).
The minor technological differences between StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) and their predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that StabiliT ER Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) are as safe and effective as the predicate devices for their intended use. Thus, StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement) are substantially equivalent to their marketed predicate devices.
i
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three faces in profile, suggesting a sense of community and diversity. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DFine Inc. % Mr. Sandeep Saboo 3047 Orchard Parkway San Jose, California 95134
DEC 30 2009
Re: K090986
Trade/Device Name: StabiliT ER Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) Regulation Number: 21 CFR 888.3027 Regulation Name: Polmethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, KIH Dated: December 17, 2009 Received: December 18, 2009
Dear Mr. Saboo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Sandeep Saboo
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Daniel Kane
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: StabiliT ERX Bone Cement and
StabiliT Vertebral Augmentation System (for use with StabiliT ERX Bone Cement)
Indications for Use:
StabiliT ER Bone Cement:
The StabiliT ER Bone Cement is intended for the treatment of pathological fractures He Stablin E. ( Bertebroplasty or kyphoplasty procedure. Painful vertebral of the vertobrato acing a vertosit from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
StabiliT Vertebral Augmentation System (for use with StabiliT ER * Bone Cement):
Ochienty.
The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of The Otablir? Vortobrament in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression treathent of pathologiod fractaros onish benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of GDRH, Offjge of Device Evaluation (ODE)
RANDALL R. ARNOLD FOR M.MEUKERSON
Page _ of _
Division of Surgical, Orthopedic, and Restorative Devices
(Division Sign-Off)
DFine Inc.
Response to Deficiency Questions - K090986 Stork) Number StabiliT ER Bone Cement, and StabiliT Vertebral Augmentation System for use with StabiliT ER* Bone Cement Page 37